Influence of a Monopoly Game on Subtle Behaviors

Obesity Clinical Trial

Official title:

Influence of a Monopoly Game on Subtle Behaviors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470949
• Other study ID #: 14-0719
• Status: Completed
• Phase: N/A
• First received: October 28, 2014
• Last updated: December 17, 2015
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project will investigate the influence of experimentally manipulated perceived social standing on eating behavior and obesity risk.

Description:

The scope of work outlined in this proposal will investigate experimentally manipulated social status on acute eating behavior, energy intake, and risk for obesity. This will be accomplished using a randomized, crossover design to place young adults in experimental high and low social status conditions. At visit 1, participants will complete baseline measurements, and then consume a standardized breakfast. In order to control for the influence of stress on eating behavior in both conditions, the participants will participate in the Stroop Test, a test known to induce stress in individuals, following breakfast. Using a computerized randomization scheme, each participant will be randomized to either the low or high social status condition (½ will receive high first; ½ will receive low first) and will receive the packet of rules and instructions for their respective condition. The participants will play Monopoly for up to 2 hours with another player they have not previously met. At the end of the game, the high social status player will be told that they won, and the low social status player will be told that they lost. The participants will participate in the Stroop Test again. Then the investigators will take the players into the Children's Eating Laboratory, where a buffet ad libitum lunch will be served in separate rooms. The participants will have 30 minutes to consume their lunch and plate waste will be measured to assess each participant's dietary intake. There will be a 4-week washout period and the second visit will be exactly like the first, except that they will participate in the alternate social status condition. The investigators will evaluate whether there was within-subject variation in dietary intakes based upon which social status condition they were placed in.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 25 Years

Eligibility

Inclusion Criteria:

• Ages 19-25

• Self-identified Hispanic ethnicity

• Born in the United States

• Body Mass Index (BMI) =18.5 and =30 kg/m2

• A score on the MacArthur scale of subjective social status =3 and =8

• No self-report of acute or chronic disease (heart disease, diabetes, gastrointestinal disorders in particular)

• No plans for extended travel (>1 week) within the next 2 months

• No current tobacco use

• Capable and willing to give informed consent, understand inclusion criteria, and accept the randomized assignment

Exclusion Criteria:

• Never played monopoly before

• Not born in the United States

• Strict dietary restrictions (vegan, vegetarian, gluten-free, dairy-free/lactose intolerant, nut-allergies)

• Participation in any weight reduction program, weight-loss diet, or other special diet within the previous 3 months

• Weight loss or gain of =10 pounds in the past 6 months for any reason except post-partum weight loss

• Currently taking medication that suppresses or stimulates appetite

• Current smoker or quit smoking less than 6 months prior

• Any major disease, including:

• Active cancer or cancer requiring treatment in the past 2 years (except nonmelanoma skin cancer).

• Active or chronic infections, including self-reported HIV positivity and active tuberculosis.

• Diagnosis of cardiovascular disease

• Gastrointestinal disease, including inflammatory bowel disease that has required treatment in the past year, celiac disease, recent of significant abdominal surgery

• Active renal disease

• Lung disease such as chronic obstructive airway disease requiring use of oxygen

• Diagnosis of diabetes (type 1 or type 2)

• Uncontrolled psychiatric disease (such as schizophrenia and bipolar disorder) that, in the opinion of the investigators, would impede conduct of the trial or completion of procedures

• A score on the Brief Symptom Inventory (BSI) (Derogatis & Melisaratos, 1983) that exceeds the 90th percentile

• History of or current eating disorders, or an Eating Attitudes Test (EAT-26) score >20.

• Conditions or behaviors likely to effect the conduct of the trial: unable or unwilling to give informed consent; unable to communicate with the pertinent clinic staff; another household member is a participant or staff member in the trial; unwilling to accept social status assignment by randomization; current or anticipated participation in another intervention research project that would interfere with the intervention offered in the trial; likely to move away from participating university before visits are completed; unable to walk 0.25 mile in 10 minutes.

• Currently taking antidepressant, steroid, or thyroid medication, unless dosage has been stable for at least 6 months.

• A recent or ongoing problem with drug abuse or addiction.

• Excessive alcohol intake, either acute or chronic, defined as any one of the following: 1) average consumption of 3 or more alcohol containing beverages daily; 2) consumption of 7 or more alcoholic beverages within a 24-hr period in the past 12 months; or 3) other evidence available to clinic staff.

• Not willing to be randomized to any of the two experimental conditions.

• Pregnancy and childbearing: currently pregnant or less than 3 months post-partum; currently nursing or within 6 weeks of having completed nursing; pregnancy anticipated during study; unwilling to report possible or confirmed pregnancies promptly during the course of the trial; unwilling to take adequate contraceptive measures if potentially fertile.

• Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Eating Behavior
• Obesity

Intervention

Behavioral:
• Manipulated Social Status
The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit.

Locations

Country	Name	City	State
United States	University of Colorado Denver-Anschutz Medical Campus	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	Brown University, University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calories Selected and Consumed following the experimental manipulation	The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.	Administered 30 days apart	No
Primary	The Macronutrient Composition of Foods Consumed	The participants will be provided with an ad libitum lunch for 30 minutes following the completion of their manipulated social status condition.	Administered 30 days apart	No
Secondary	Body Mass Index	Height and Weight will be measured	Measured 30 days apart	No